Butyrate Therapy for Type 1 Diabetes

Overseen By Amy Zipse

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Must be taking: Insulin

Disqualifiers: Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new tablet called BKR-017, which delivers butyrate to the colon, in people with type 1 diabetes. The goal is to see if it helps improve blood sugar control and reduce triglycerides over a few months.

Research Team

Adrian Vella, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 20-80 with Type 1 Diabetes, who are patients at the Mayo Clinic Endocrinology Clinic. They must have an HbA1c level of 6.4-8.9%, a BMI under 30, and low C-Peptide levels (<0.5 ng/mL). Participants cannot be on any T1D treatments other than insulin and must not be pregnant or unable to consent.

Inclusion Criteria

I am between 20 and 80 years old with type 1 diabetes and a C-Peptide level below 0.5 ng/mL.

My HbA1c is between 6.4-8.9% and my BMI is under 30.

Exclusion Criteria

I only use insulin to manage my Type 1 Diabetes.

Pregnancy

Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conventional Therapy

Participants receive usual therapy for the first study period

4 weeks

Treatment

Participants receive 500 mg Butyrate tablets at a dose of 1.5 g twice daily

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BKR-017

Trial Overview The trial is testing BKR-017, which are butyrate tablets aimed at the colon, as an additional treatment to improve metabolic control in people with Type 1 Diabetes.

Participant Groups

Group I: Conventional Therapy / Butyrate Experimental Treatment 1 Intervention

Subjects will be receiving usual therapy for the first study period (approx 1 month) then 500 mg Butyrate tablets to be taken at a dose of 1.5 g (3 tablets) twice daily (BID) for approx 2 months

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

BioKier Inc.

Industry Sponsor

Trials

5

Recruited

120+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+